Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3
研究概览
简要总结
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
详细描述
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
Objective(s):
The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR < 1.0 BPM during spontaneous breathing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 18 years old;
- •The subject has given written informed consent to participate in the study;
- •The subject is both willing and able to comply with study procedures.
排除标准
- •The subject has a history of or current atrial fibrillation;
- •The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds;
- •The subject has an implanted pacemaker;
- •The subject has had any relevant injury at the sensor location site (self-reported);
- •The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
- •The subject is currently or trying to get pregnant (self-reported); and/or
- •The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
结局指标
主要结局
Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3
时间窗: 40 minutes
Measure respiratory rates
次要结局
未报告次要终点